R&D Engineer

Position Summary

This Morrisville, NC based Research & Development Engineer is responsible for the development and maintenance of Anesthesia and Emergency Medicine products. Experience should focus on Research and Development of Medical Devices. The incumbent in this position leads multiple projects and ensures development phases are completed in a timely manner.  The projects span all phases of development, including creation of new designs, creative iterations and enhancements for existing products, and modifications to product designs.   Products can include all classifications (i.e. Class I, IIa, IIb and III).  

The candidate must be capable of advanced level scope of assignments in planning, designing, and coordinating the development and implementation of related engineering activities to new products and improvements to existing products lines; as well as and implement successfully into manufacturing. Incumbent at this level self-manages their project work, seeks help when required, and is fully aware of the operating procedures and policies of the work unit.
 

Principal Responsibilities

•    Executes projects associated with the design and development of medical devices from concept to commercialization working with marketing, clinical, sales staff and customers to define and refine product requirements and specifications.
•    Responsible for the technical design decisions on new product development working with internal manufacturing and/or external suppliers developing new designs and processes or design improvements that require creative problem solving and design ingenuity.
•    Resolves complex process/product development and manufacturing issues; independently takes lead of working cross functional teams.
•    Prepares formal documentation of the product designs, change management, risk analysis, product requirements and specifications, customer needs, etc. according to established product development procedures.  Initiates formal reviews to progress projects to compliant completion. 
•    Prepares or coordinates development of design drawings, specifications, estimates of costs, documentation updates, etc. Utilizes appropriate PLM, ERP and other product-related database systems.
•    Conducts research on projects associated with the design and/or design modifications of medical devices, components, models, or mechanisms.
•    Investigates and resolves technical production problems involving product performance.
•    International efforts (travel, interface) are key, as role supports new product development and sustaining engineering efforts for the manufacturing plants as applicable.  Teleflex is a global organization with manufacturing facilities in the US, Mexico, Czech Republic, Malaysia, India and Germany.
•    Demonstrates professional responsibilities by cooperating with other personnel to achieve department objectives and maintain good employee relations, interdepartmental objectives, and departmental goals and objectives.
 

Education / Experience Requirements

•    Bachelor’s Degree in Engineering
•    Minimum 3-5 years of work experience in the development of devices within the medical device industry. Prior work in testing, validation and/or sustaining engineering is preferred, with close partnerships with manufacturing teams.  
•    Experience in SolidWorks CADD (design/drafting) program preferred
•    Microsoft Office Suite (Project, Word, Excel) required
•    Injection molding, plastic extrusion, plastic part assembly, coatings, and metal component fabrication knowledge is a plus.
•    Experience working within the medical device-related industry requirements (FDA, MDD, MDR, ISO Standards, etc).
•    Relational database experience (such as Oracle Agile) and ERP experience (SAP, Oracle) a plus
•    Testing experience using ISO and ASTM testing methods for medical devices and general plastic components preferred.
•    Demonstrated principles and practices of professional engineering a plus.
 

Specialized Skills / Other Requirements

Skill Sets:
•    Strong written and verbal communication skills and attention to detail. 
•    Effectively present information and respond to questions from groups of customers, peers, managers, senior leadership.
•    Solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists; interprets a variety of instructions furnished in written, oral, diagram, or schedule form.
•    Analyze complex, technical, and administrative problems and adopt an effective course of action.
•    Make effective presentations to, and participate in a variety of meetings and conferences with other companies 
Ability To:
•    Demonstrate creativity and ingenuity in applying engineering principles and practices.
•    Draw solutions form a wider range of experience.
•    Organize, evaluate, and coordinate engineering studies with professional, technical, and clerical staff of a product evaluation department.
•    Conduct comprehensive studies and preparation of reports including recommendations.
•    Prepare clear and concise statements and reports.
•    Establish and maintain cooperative relations with those contracted in the workplace.
•    Speak and write English fluently.
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